FDA Events for Third Harmonic Bio (THRD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Third Harmonic Bio (THRD).
Over the past two years, Third Harmonic Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
THB335. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
THB335 - FDA Regulatory Timeline and Events
THB335 is a drug developed by Third Harmonic Bio for the following indication: In chronic spontaneous urticaria.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- THB335
- Announced Date:
- February 11, 2025
- Indication:
- In chronic spontaneous urticaria
Announcement
Third Harmonic Bio, Inc. announced results from its Phase 1 single and multiple ascending dose (SAD/MAD) clinical trial of THB335 in healthy volunteers.
AI Summary
Third Harmonic Bio, Inc. announced positive results from its Phase 1 trial of THB335, a potent and selective oral KIT inhibitor, tested in healthy volunteers using both single and multiple ascending dose (SAD/MAD) protocols. The study, which tested doses ranging from 21 mg to 205 mg, demonstrated that THB335 has a half-life of approximately 40 hours, allowing once-daily dosing. Researchers observed dose-dependent increases in drug exposure and significant reductions in serum tryptase levels, a marker for mast cell activation, indicating potential for clinical benefit in treating chronic spontaneous urticaria (CSU) at doses of 41 mg and above.
Overall, THB335 was found to be safe and well tolerated, with only minor, mostly transient, adverse effects. The encouraging Phase 1 data support advancing THB335 into a Phase 2 clinical trial in CSU patients, as the company continues its efforts to further develop and optimize this promising treatment option.
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Third Harmonic Bio FDA Events - Frequently Asked Questions
As of now, Third Harmonic Bio (THRD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Third Harmonic Bio (THRD) has reported FDA regulatory activity for THB335.
The most recent FDA-related event for Third Harmonic Bio occurred on February 11, 2025, involving THB335. The update was categorized as "Results," with the company reporting: "Third Harmonic Bio, Inc. announced results from its Phase 1 single and multiple ascending dose (SAD/MAD) clinical trial of THB335 in healthy volunteers."
Currently, Third Harmonic Bio has one therapy (THB335) targeting the following condition: In chronic spontaneous urticaria.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:THRD) was last updated on 7/14/2025 by MarketBeat.com Staff
